Role Summary

Axtria is seeking an exceptional leader to build and scale its AI-Powered Pharmacovigilance (PV) practice within the Clinical Solutions business. This role targets the highest AI-to-effort ROI in the drug safety domain: intelligent signal detection and automated PBRER/PSUR authoring. You will design and deliver multi-source NLP signal fusion pipelines, LLM-driven regulatory report generation with full audit traceability, benefit-risk quantification using Monte Carlo simulation, and GVP-module-aligned inspection readiness simulators. Acting as the primary SME, you will position Axtria as the go-to partner for pharma and biotech safety organizations seeking to transform labor-intensive PV workflows through responsible, regulator-ready AI

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Core Responsibiliti
esStrategic Leadersh
ipDefine and execute the vision for AI-Powered PV within Axtria’s Clinical Solutions COE, with a deliberate focus on signal detection automation and LLM-assisted regulatory authoring as the primary value driver
s.Supervise Associate Directors, NLP engineers, safety scientists,



and delivery leads — ensuring scientific rigor, regulatory defensibility, and delivery excellence across all program
s.Maintain high CSAT and NPS scores to ensure customer satisfaction and long-term client relationship

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Multi-Source Signal Detection & NLP Fusion Pipel
ineArchitect and productionize end-to-end NLP pipelines that ingest and harmonize spontaneous reports (FAERS, EudraVigilance, VigiBase), structured EHR data, and biomedical literature (PubMed, EMBASE) into a unified signal detection layer — eliminating siloed, source-by-source manual revi
ew.Lead development of entity recognition, relationship extraction, and case-narrative understanding models tuned to MedDRA ontology, WHO-ART coding, and ICH E2B(R3) data standar
ds.Implement disproportionality analysis (ROR, PRR, EBGM) augmented with ML-based signal ranking to prioritize true safety signals and suppress noise, with transparent confidenc

📌 Director - Pharmacovigilance (Noida)
🏢 Axtria - Ingenious Insights
📍 Noida